Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000535471
Ethics application status
Approved
Date submitted
13/01/2025
Date registered
27/05/2025
Date last updated
27/05/2025
Date data sharing statement initially provided
27/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of citrus sinensis (sweet orange) peel extract on serum glucose and lipids levels in patients with Type 2 Diabetes: A Randomised Control Trial.
Scientific title
The effect of Citrus sinensis peel extract on serum glucose and lipids levels in patients with T2DM aged 35 to 75 years: A Randomised control trial.
Secondary ID [1] 313881 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II diabetes mellitus (T2DM) 336279 0
Dyslipidemias 336280 0
Condition category
Condition code
Metabolic and Endocrine 332820 332820 0 0
Diabetes
Cardiovascular 332821 332821 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
T2DM Patients in the Study group will be given citrus sinensis peel extract prepared as powdered form and 500mg once daily for 6 months with 100ml water or plain yogurt as preferred by the patients. The participants will be asked to maintain a memo on their phone indicating that they took the capsule. They will continue their standard medical care (metformin for their diabetes and statins (any type) for their dyslipidemias.
Intervention code [1] 330291 0
Treatment: Other
Comparator / control treatment
The control group will be type 2 diabetes patients with dyslipidemias taking standard medical care (metformin and statins)
Control group
Active

Outcomes
Primary outcome [1] 340348 0
Proportion of patients with a reduction in blood glucose levels
Timepoint [1] 340348 0
Baseline, 1, 3 and 6 months post commencement of intervention. Proportion of patients with a reduction in blood glucose levels will be assessed at the conclusion of study
Primary outcome [2] 340349 0
Proportion of patients with reduced serum lipid levels at the end of study
Timepoint [2] 340349 0
Baseline, 1 ,3 and 6 months post commencement of intervention, the proportion of patients with reduced serum lipid levels will be assessed at the conclusion of data collection, i.e., 6 months after enrolling last participant.
Secondary outcome [1] 443778 0
Nil
Timepoint [1] 443778 0
nil

Eligibility
Key inclusion criteria
All T2DM patients with dyslipidemias presenting to outdoor dept. on Metformin and Statins therapy
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Any previous Myocardial Infarction (MI)
Type 1 diabetes
Patients on Insulin therapy
Any other comorbidities like liver or kidney failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization via rolling dice
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
T-test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2024
Date of last participant enrolment
Anticipated
Actual
11/07/2024
Date of last data collection
Anticipated
Actual
20/12/2024
Sample size
Target
180
Accrual to date
Final
175
Recruitment outside Australia
Country [1] 26820 0
Pakistan
State/province [1] 26820 0
Punjab

Funding & Sponsors
Funding source category [1] 318160 0
Hospital
Name [1] 318160 0
Multan medical and dental college ibn e seina hospital multan Pakistan
Country [1] 318160 0
Pakistan
Primary sponsor type
Individual
Name
Dr Zeemal iqbal - Multan Medical & Dental College, Ibn-e-seina Hospital Multan
Address
Country
Pakistan
Secondary sponsor category [1] 320542 0
None
Name [1] 320542 0
Address [1] 320542 0
Country [1] 320542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316807 0
Multan Medical and Dental college Ethical Review comittee
Ethics committee address [1] 316807 0
Ethics committee country [1] 316807 0
Pakistan
Date submitted for ethics approval [1] 316807 0
12/05/2022
Approval date [1] 316807 0
23/05/2022
Ethics approval number [1] 316807 0
No: 05/MMDC/ERC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139066 0
Dr Zeemal Iqbal
Address 139066 0
Multan medical & dental college, Ibn-e-seina hospital & research institute, Southern Bypass Jahangirabad, Multan Pakistan. P.O Box #848 New Multan
Country 139066 0
Pakistan
Phone 139066 0
+923124506970
Fax 139066 0
Email 139066 0
[email protected]
Contact person for public queries
Name 139067 0
Zeemal Iqbal
Address 139067 0
Multan medical & dental college, Ibn-e-seina hospital & research institute, Southern Bypass Jahangirabad, Multan Pakistan. P.O Box #848 New Multan
Country 139067 0
Pakistan
Phone 139067 0
+92616782879
Fax 139067 0
Email 139067 0
[email protected]
Contact person for scientific queries
Name 139068 0
Zeemal Iqbal
Address 139068 0
Multan medical & dental college, Ibn-e-seina hospital & research institute, Southern Bypass Jahangirabad, Multan Pakistan. P.O Box #848 New Multan
Country 139068 0
Pakistan
Phone 139068 0
+92616782879
Fax 139068 0
Email 139068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24507Ethical approval    niaz baloch.pdf
24508Informed consent form    CONSENT FORM.docx
24509Study protocol    Synopsis Final.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.